1. Field of the Invention
The present invention relates to food bars for consumption by pregnant women, lactating women, or women having childbearing potential that are attempting to become pregnant containing one or more vitamins and/or minerals, and one or more anti-constipation and regularity-maintaining agents, to methods for preparing these food bars, and to methods for enhancing the nutrition of pregnant women and their developing fetuses, of lactating women and their babies, and of women having childbearing potential that are attempting to become pregnant. In particular, the present invention relates to food bars comprising one or more vitamins and/or minerals recommended for consumption by pregnant women, lactating women, or women having childbearing potential that are attempting to become pregnant in an amount that is effective for enhancing the nutrition of pregnant women, lactating women, or women having childbearing potential that are attempting to become pregnant, or of their developing fetuses or babies, and one or more anti-constipation and regularity-maintaining agents in an amount that is effective for reducing or eliminating constipation, and/or for maintaining regularity of bowel movements, in pregnant women, lactating women, or women having childbearing potential that are attempting to become pregnant.
2. Background
The daily Recommended Dietary Allowances of water-soluble vitamins for non-pregnant and pregnant women, and the rationale for increased allowances during pregnancy, is set forth in Nutrition During Pregnancy (Nat""l Academy Press, 1990), and below.
The daily Recommended Dietary Allowances (RDAS) and Estimated Safe and Adequate Daily Dietary Intakes (ESADDIs) compared with the U.S. Recommended Daily Allowances (U.S. RDAs) established by the U.S. Food and Drug Administration of protein, vitamins and minerals for non-pregnant, pregnant and lactating women is set forth in Nutrition During Pregnancy (Nat""l Academy Press, 1990), and below.
Morning sickness generally causes a loss of appetite and a feeling of nausea, and is experienced by a significant number of pregnant women. Because they experience morning sickness, and because the pills that contain the full dose of recommended prenatal vitamins and minerals generally are very large in size, many pregnant women are often reluctant to take their prenatal vitamin and mineral pills. Further, when they do take these pills, these pregnant women often experience difficulty swallowing and retaining these pills, and take the pills without food. Vitamins and minerals that are taken without food are not absorbed as well as those taken with some food. Problems, thus, arise concerning patient compliance (the daily consumption of vitamin and mineral supplements), maintaining or enhancing the health of pregnant woman, and the absorption of the quantity of vitamins and minerals that are associated with proper fetal development. Moreover, regurgitation after consuming a vitamin and mineral pill causes loss of some or all of the nutrients that were originally present in the pill.
Morning sickness generally occurs most frequently during the first trimester of pregnancy. Defects in the neural tube of a developing fetus (spina bifida) can also occur during the first trimester of pregnancy, for example, during the first month of gestation, before a woman may have become aware of her pregnancy. These defects are known to be linked to an inadequate intake of folic acid. It is well known that folic acid prevents neural tube defects. Thus, folic acid should be consumed in sufficient quantities by women of child-bearing ages. Folic acid has also been shown to have beneficial cardiac effects, and to decrease the risk of cervical dysplasia.
Calcium is critical for proper fetal development, and is essential for the production of milk by women. The administration of calcium to a pregnant or lactating woman also acts to prevent early osteoporosis in the woman as a result of a calcium drain in the woman during pregnancy or lactation.
A recent University of North Carolina at Chapel Hill study that was described in an article appearing in a November, 2000, issue of Science Daily magazine and entitled, xe2x80x9cNew Research Shows Calcium Deficiency Permits Faster Lead Release from Pregnant Women""s Bones,xe2x80x9d showed that pregnant women who do not consume enough calcium in their diets, or through supplements, show greater increases in lead in their bloodstreams than pregnant women with normal calcium levels. Bone tissue, which contains about 95% of the body""s lead, demineralizes more rapidly in pregnant women who are getting less calcium in comparison with other pregnant women. Such demineralization releases locked-up lead into the blood, particularly during the second half of pregnancy, and may cause harm to both pregnant women and their fetuses. (Past research has linked lead to many adverse conditions, including nervous system and possible cardiovascular problems.) This study also showed that calcium consumption can minimize bone demineralization in pregnant women, and that one variable associated with a reduced lead level is a higher calcium intake. Calcium intake at the recommended daily allowance level was found to protect somewhat against lead, and higher calcium levels were found to correspond with even less lead. The protective effect of calcium was found to become stronger as pregnancy progressed.
Many other vitamins, minerals and other nutritional supplements, such as those set forth hereinabove, are recommended for pregnant and lactating women.
The classical solid dosage forms that have been used as delivery systems for nutritional supplements, such as prenatal vitamins and minerals, for pregnant and lactating women, for example, tablets and capsules, have known concerns about their proper disintegration and dissolution, and about the bioavailablity of the nutritional supplements contained therein, and are often harsh on the stomach. Further, these tablets and capsules generally cannot contain more than about 500 mg of calcium, which is much lower than the Recommended Dietary Allowance established for pregnant women.
Unfortunately, pregnancy and lactation often interrupt the regularity of women""s bowel movements, and cause women to become constipated (to experience difficulties having regular and comfortable bowel movements). This, in turn, often results in the women experiencing painful and unattractive hemorrhoids. The constipation experienced by pregnant and lactating women is often exacerbated by the effects of pre-natal doses of vitamins and/or minerals, in particular, iron.
It would be beneficial to provide a product that is high in nutritional value for pregnant women, lactating women, and women having childbearing potential that are attempting to become pregnant that properly disintegrates and dissolves, thereby allowing the nutrients present therein to become bioavailable for the consumer, that is gentle on the stomach, that encourages patient compliance, that reduces or eliminates constipation, making excretion more regular and comfortable, and that contains a large quantity of calcium.
The food bars of the present invention advantageously are desirable-tasting, are easily chewable, are gentle on the stomach, and supplement the nutritional requirements of pregnant women, lactating women, and women having-childbearing potential that are attempting to become pregnant. These food bars generally contain a dispersed system of slowly-released vitamins and/or minerals in a stable matrix for oral ingestion and absorption. The food bars readily disintegrate and dissolve, are digestible, and provide a bio-available form of nutritional supplementation for pregnant women, lactating women, and women having childbearing potential that are attempting to become pregnant. Because the food bars are not in the form of large pills, tablets or capsules, and have a desirable taste, these food bars also provide for an improved patient compliance with the daily regime of consuming vitamin and mineral supplements during an often difficult period of time. Further, because they contain one or more anti-constipation and regularity-maintaining agents, the food bars of the invention generally help maintain regular bowel movements and reduce or eliminate constipation, and associated painful and unattractive hemorrhoids, which may occur during pregnancy or lactation, or which may be a side effect resulting from the consumption of certain nutritional supplements, such as iron. Thus, the food bars of the invention permit the maintenance of more regular and comfortable excretions of bowel movements by pregnant women, lactating women, and women having childbearing potential that are attempting to become pregnant. The food bars of the invention overcome the shortcomings of other prenatal or lactation vitamin and mineral supplements, such as large vitamin pills, and deliver to pregnant women, lactating women, and women having childbearing potential that are attempting to become pregnant specific doses of vitamins, minerals and/or other nutritional supplements in a bio-available absorption format. As a result of folic acid that may be present therein, the food bars of the invention may also have beneficial properties protecting against neural tube defects. In addition, these food bars have the ability to deliver the Recommended Dietary Allowance, or higher levels, of calcium in a bio-available form to pregnant women, lactating women, and women having childbearing potential that are attempting to become pregnant. These are significantly greater quantities of calcium than can be effectively delivered in a prenatal vitamin pill, tablet or capsule. Further, the dispersed system of the food bars, along with the chewing action of the women during consumption, diminishes the concerns related to the disintegration and dissolution of the classical solid dosage forms, and the bioavailablity of the nutritional supplements contained therein.
3. Description of the Related Art
The Physicians"" Desk Reference (49th Edition, 1995, and 54th Edition, 2000) describes a prenatal vitamin and mineral tablet marketed by Lederle Laboratories (Waynem, N.J.) under the trademark name Materna(copyright) (pages 1264 and 1534, respectively).
U.S. Pat. No. 2,634,210 discloses chocolate food products, including bars (FIGS. 1 and 2), having two or more layers, and vitamins and minerals dispersed in one or more of the layers. This patent does not describe single-layer food bars, the use of anti-constipation and regularity-maintaining agents or folic acid in food bars, or the administration of food bars to pregnant or lactating women.
U.S. Pat. No. 3,814,819 discloses a protein fortified food bar of a controlled calorie content that contains a vitamin and mineral mixture, and that is composed of several crisp wafers stacked one above the other with a creamy filling between the wafers. This patent does not describe single-layer food bars, the use of anti-constipation and regularity-maintaining agents or folic acid in food bars, or the administration of food bars to pregnant or lactating women.
U.S. Pat. No. 4,018,901 discloses a high protein food bar that has a marshmallow matrix as a base, and a water activity less than 0.85, and that may include fat-coated vitamins. This patent does not describe the use of anti-constipation and regularity-maintaining agents or folic acid in food bars, or the administration of food bars to pregnant or lactating women.
U.S. Pat. No. 4,038,423 discloses a food bar having a base containing marshmallow fortified with a high protein ingredient of reduced water binding capability, and a coating containing fat-coated vitamins. This patent does not describe the use of anti-constipation and regularity-maintaining agents or folic acid in food bars, or the administration of food bars to pregnant or lactating women.
U.S. Pat. No. 4,710,387 discloses a nutritional supplement preparation (a powder material in Example 1, and a milk-like drink in Example 2) for pregnant and breast-feeding women containing 10-20% by weight of protein, 16-28% by weight of fat, 43-65% by weight of carbohydrates, 3.5% by weight of moisture, and one or more minerals, trace elements and vitamins, such as calcium and folic acid. This patent does not describe food bars, or the use of anti-constipation and regularity-maintaining agents.
U.S. Pat. No. 4,751,085 discloses vitamin compositions containing taurine (2-aminoethanesulfonic acid) provided either alone or in food products, such as enriched breads, ready-to-eat cereals and breakfast beverages. This patent does not describe food bars.
U.S. Pat. No. 5,126,150 discloses a baked cookie containing calcium lactate coated psyllium fiber, insoluble dietary fiber, shortening, flour, sugar and water for use in the control of bowel function (including as a laxative). This patent does not describe food bars, the use of folic acid in food bars, or the administration of food bars to pregnant or lactating women.
U.S. Pat. No. 5,494,678 discloses multi-vitamin and mineral supplements for incorporation into tablets, powders, granules, beads, lozenges, capsules and liquids, and administration to a pregnant woman during her first, second and third trimesters of pregnancy. The supplements contain specific regimens of a calcium compound, vitamin D, folic acid, vitamin B12, vitamin B6, and vitamin B1. This patent does not describe food bars or anti-constipation and regularity-maintaining agents.
U.S. Pat. No. 5,571,441 discloses nutritional supplement compositions containing vitamins, minerals, central nervous system bracers, such as caffeine, and flavenols, that are coadministered in the form of a tablet or capsule, as a powder, or as a liquid form. This patent does not describe food bars or the administration of vitamins or minerals to pregnant or lactating women.
U.S. Pat. Nos. 5,654,011 and 6,040,333 disclose vitamin- and mineral-containing dietary supplements, including dietary bars, for supplementing the dietary needs of women and preventing or reducing life stage associated health risks during each of their principal adult life stages (childbearing or pre-perimenopause, perimenopause and menopause, or post-menopause). These patents do not describe anti-constipation and regularity-maintaining agents.
U.S. Pat. No. 5,869,084 discloses multi-vitamin and mineral supplements for administration to lactating, non-lactating (but not pregnant) and menopausal women in the form of tablets, powders, granules, beads, lozenges, capsules or liquids. This patent does not disclose food bars, or the administration of vitamins or minerals to pregnant women.
U.S. Pat. No. 5,906,833 discloses nutritional supplements, including food bars, that contain vitamins. This patent does not describe the use of folic acid or calcium in food bars, anti-constipation and regularity-maintaining agents or the administration of food bars to pregnant or lactating women.
U.S. Pat. No. 6,039,978 discloses a dietary food enhancement agent for fortifying food products (meats, rolls, muffins, breads, sauces, desserts, soups, potatoes, rice, cereals or fruit or vegetable juice beverages). The agent contains a pre-mixed combination of calcium, folic acid and other vitamins and minerals. The nutritional enhancement is administered to a patient having at least one dietary response condition, such as obesity, hypertension, hyperlipidemia, cancer or diabetes. This patent does not describe the administration of food bars to pregnant or lactating women.
The present invention provides food bars for consumption by pregnant women, lactating women, or women having childbearing potential that are attempting to become pregnant containing one or more vitamins and/or minerals and one or more anti-constipation and regularity-maintaining agents. The food bars supplement the dietary requirements of pregnant women, lactating women and women having childbearing potential that are attempting to become pregnant. They generally comprise one or more vitamins and/or minerals recommended for consumption by pregnant women, lactating women or women having childbearing potential that are attempting to become pregnant in an amount that is effective for enhancing the nutrition of pregnant women, lactating women, or women having childbearing potential that are attempting to become pregnant, or of their developing fetuses or babies, one or more anti-constipation and regularity-maintaining agents in an amount that is effective for maintaining bowel movement regularity and/or reducing or eliminating constipation, from about 0 to about 99 weight percent of carbohydrates, from about 0 to about 80 weight percent of proteins, and from about 0 to about 60 weight percent of fats.
Vitamins, minerals and/or other nutritional supplements that may be present in the food bars of the invention include protein, Vitamin A, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B6, Vitamin B9/M, Vitamin B12, Vitamin C, Vitamin D, Vitamin E, Vitamin K, Niacinamide, Tocopheryl, Calcium, Iron, Phosphorus, Pantothenic Acid, Iodine, Magnesium, Biotin, Folacin, Zinc, Selenium, Copper, Manganese, Chromium, Molybdenum, Choline, Fluoride, Chloride, Potassium, Sodium, Docosahexaenoic Acid (DHA) or Calcium Polycarbophil. The quantity of vitamins, minerals and other nutritional supplements that is present in the food bars of the invention is a quantity that is not harmful to pregnant women, lactating women, or women having childbearing potential that are attempting to become pregnant, or to their developing fetuses or babies.
The food bars of the invention may readily be prepared in a cost-effective manner using standard machinery and techniques, and have a shelf life of approximately six to twenty-four months at normal room temperature.
The present invention also provides methods for preparing these food bars, and methods for supplementing the dietary requirements of pregnant women, lactating women and/or women having childbearing potential that are attempting to become pregnant.